United States Food and Drug Administration (USFDA) has completed an unannounced inspection of Rubicon Research’s manufacturing facility located at J4/2, Additional MIDC, Satara, Maharashtra, India. The inspection was conducted from October 5, 2026 to October 9, 2026.
Upon conclusion of the current inspection, a Form 483 containing 1 observation was issued to the company. The observation is procedural in nature and does not relate to data integrity. The company is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner.
A successful inspection outcome for the Satara facility would be the first successful unannounced inspection for this site. The previous inspection in January 2023 was the first ever USFDA inspection on for the site, for which the company was provided prior intimation. Upon conclusion, this would be the third successful unannounced US FDA inspection for the company in FY2026- 27, considering the inspections of Toronto (Canada) R&D facility in April 2026 and Pithampur (India) manufacturing facility in July 2026.
Additionally, the company’s recently acquired manufacturing facility in East Brunswick, New Jersey, USA was inspected by the USFDA in May 2026, just prior to its acquisition of that facility in July 2026.
Rubicon Research is a pharmaceutical formulations company, driven by innovation through focused research and development, with an increasing portfolio of speciality products and drug-device combination products targeting regulated markets and in particular the United States.
